Acellular Matrix From Human Dermis in Combination With Orthobiologic Stimuli for Augmentation of Massive Rotator Cuff Tears (MODA)

Istituto Ortopedico Rizzoli

Status: Enrolling

Conditions: Rotator Cuff Tears

Treatments: Other: Acellular Dermal Matrix; Other: Acellular Dermal Matrix with autologous orthobiologics

Study type: Interventional

Funder types: Other

Identifiers

NCT05855759

MODA

Details and patient eligibility

About

The use of biologic acellular matrices for the surgical augmentation of rotator cuff lesions has greatly expanded inrecent years. The study team patented a method for removing cells from human dermis (Acellular Dermal Matrix), maintaining unaltered biological and structural integrity. Acellular Dermal Matrix has been succesfully used for rotator cuff surgical repair augmentation beside in a limited number of patients. The aim of the project is to demonstrate the therapeutical efficacy of this strategy in patients affected by rotator cuff massive tears. Acellular Dermal Matrix will be also combined with autologous orthobiologics.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients affected by large to massive lesion according to Gerber involving supraspinatus and infraspinatus tendons
• tendon retraction <=3 according to Thomazeau
• fatty degeneration <=3 according to Goutallier
• possibility to obtain tendon reduction,
• pre-operative Magnetic Resonance Imaging,
• ability to read, understand and complete outcome scores

Exclusion criteria

• patients affected by osteoarthritic degeneration,
• frozen shoulder,
• symptomatic acromioclavicular arthritis,
• revision surgeries,
• inability to cope with post-operative rehabilitation regimen,
• autoimmune connective tissue disease,
• current or past hematologicaldisorders,
• comorbidities affecting healing,
• active infections,
• cancers,
• pregnancy and lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups

Acellular Dermal Matrix

Active Comparator group

Description:

Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix

Treatment:

Other: Acellular Dermal Matrix

Acellular Dermal Matrix with autologous orthobiologics

Experimental group

Description:

Enrolled patients will be randomly assigned to the suture-bridge technique with acellular dermal matrix with orthobiologics autologous: humeral bone marrow concentrate and subacromial bursa

Treatment:

Other: Acellular Dermal Matrix with autologous orthobiologics